USP India, United States Pharmacopoeia's Indian chapter, will focus on developing and revising its standard setting activities in India, said Ashok Dang, senior manager of USP-India Ltd.
Janet Woodcock, director of the Center for Drug Evaluation and Research for the US Food and Drug Administration, spoke at the Drug, Chemical, and Associated Technologies Association (DCAT) annual dinner earlier this month, emphasizing the need of regulators and industry to meet the challenge of securing an increasingly complex global pharmaceutical supply chain. Her words were very well taken and show the recognition not only by FDA and other regulatory authorities, but also of pharmaceutical manufacturers and their suppliers, that the elongation of the global supply chain brings with it new responsibilities and ways of doing business.
Daiichi Sankyo Company has brought patent infringement litigation against 13 generics companies for the substance patent (2008845) and usage patent (1659502) for Levofloxacin Hydrate (brand name: Cravit tablets and Cravit fine granules). Levofloxacin Hydrate broad-spectrum oral anti-bacterial agents originated by Daiichi Sankyo, has been marketed by the company in Japan since 1993.
In view of planning commission's objection to its Rs 560-crore Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS), the Department of Pharmaceuticals (DoP) has asked the ministry for small and medium enterprise (MSME) to improve the Credit Linked Capital Subsidy Scheme (CLCSS) to make it more attractive and beneficial to the pharma units to upgrade their units as per the revised scheduled M.